MedDataX Logo

Fibromyalgia Acupuncture Study

NCT ID: NCT00882271

Last Updated: 2011-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The acupuncture treatment in this study is particularly aimed at reducing the pain and other negative health events such as emotional trauma and disability associated with Fibromyalgia, while improving the quality of life and promoting general health.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

It is hypothesized that acupuncture treatment will be effective in reducing pain and improving lower body strength and overall functionality more than the sham acupuncture treatment in people with Fibromyalgia (FM). The purpose of this study is to compare the efficacy of acupuncture with simulated acupuncture in patients with FM using a randomized controlled design. More specifically, the objectives of this study are to determine if acupuncture can (1) reduce pain, (2) improve lower body strength, and (3) improve overall functionality.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fibromyalgia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Fibromyalgia Acupuncture Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Traditional Chinese Acupuncture

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

Ten Acupuncture treatments within six weeks

2

Placebo Acupuncture

Group Type PLACEBO_COMPARATOR

Acupuncture

Intervention Type OTHER

Ten Acupuncture treatments within six weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Acupuncture

Ten Acupuncture treatments within six weeks

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Participants must be 18 years or older and can be of either sex.
2. A confirmed diagnosis of FM (pain for more than three months) will be required to participate in the study. If they do not have a diagnosis the study clinician or research assistant will examine them and determine their eligibility.
3. All participants must be willing to provide a written informed consent prior to participation and should not have undergone acupuncture treatment in the past.

Exclusion Criteria

1. Acupuncture treatment in the past five years.
2. Unwilling to sign informed consent.
3. Less than a score of 40 on the Fibromyalgia Impact Questionnaire,
4. Involvement in any litigation currently or in the past,
5. Simultaneous infection with HIV/Hepatitis B virus.
6. Severe depression (Beck depression score \>21),
7. History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
8. Serious or unstable cardiovascular, hepatic, renal, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical conditions (including unstable hypertension, hypo or hyperthyroidism, or psychological conditions that in the opinion of the investigators would compromise participation or be likely to lead to an adverse response, including injuries or hospitalization, during the course of the study. We will get the information from the health/activity questionnaire.
9. Have any DSM-IV Axis (major depression, addiction, anxiety) disorder which, in the judgment of the investigators, would interfere with compliance with the study protocol.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Southern California University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sivarama Vinjamury

Fibromyalgia Acupuncture Study

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sivarama P Vinjamury, MD, MAOM

Role: PRINCIPAL_INVESTIGATOR

Southern California University of Health Sciences

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.scuhs.edu

Visit Southern California University of Health Sciences Website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SCU-08-VINJ003

Identifier Type: -

Identifier Source: org_study_id